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Sept. 23 — Biosimilar developers and patients may have to wait another year for an FDA draft
guidance on biosimilar interchangeability, according to the agency.

The Food and Drug Administration's biosimilar user fee reauthorization
commitment letter, released Sept. 16, states that the agency will issue the draft guidance sometime
before Dec. 31, 2017.

As recently as June 20, Leah Christl, associate director for therapeutic biologics
in FDA's Office of New Drugs, told an Alliance for Health Reform briefing on biosimilars
that the interchangeability guidance would be released later in 2016 (10 LSLR 13, 6/24/16).

Leigh Purvis, director of health services research in AARP's Public Policy Institute,
told Bloomberg BNA in a Sept. 23 e-mail, “Interchangeability will be key to achieving
the expected savings from biosimilars. The fact that we’re still waiting on guidance
over six years after the enactment of the Biologics Price Competition and Innovation
Act (BPCIA)—and that the publication date remains a moving target—is extremely concerning.
Patients taking expensive biologic drugs literally can’t afford to keep waiting.“

In the Sept. 16 letter, which includes the agency's performance goals and procedures
for the Biosimilar Biological Product User Fee Act (BsUFA) reauthorization for fiscal
years 2018-2022, the FDA also said that it will work to issue a revised draft or final
guidance on interchangeability within two years after the close of the public comment
period of the initial draft, which would mean the end of 2019.

All Approvals So Far for Biosimilars

A biosimilar is a biological product that is approved by the FDA based on a showing
that it is highly similar to an already approved biological product, known as a reference
product
(RP), or brand biologic. The BPCIA, part of the Affordable Care Act, created a streamlined
approval process for biosimilars.

On further review by the FDA, the biosimilar can be designated as interchangeable
with the RP, which means that a pharmacist could substitute the biosimilar with the
RP without a physician's approval.

Since the BPCIA became law in 2010, the FDA has approved four biosimilars: Sandoz's
Zarxio
(filgrastim-sndz), a biosimilar of Amgen's cancer treatment Neupogen, in March 2015;
Pfizer and Celltrion's Inflectra (infliximab-dyyb), a biosimilar of Johnson & Johnson's
arthritis treatment Remicade, on April 5; Sandoz's Erelzi (etanercept-szzs), a biosimilar
of Amgen's arthritis drug Enbrel; and Amgen’s ABP 501, to be sold as Amjevita
(adalimumab-atto), a biosimilar of AbbVie’s top-selling anti-inflammatory drug Humira,
on Sept. 23. None has been designated as interchangeable.

Industry Reaction Favorable Overall

The FDA will hold a public meeting to discuss proposed recommendations for the reauthorization
of BsUFA on Oct. 20 at the agency's White Oak campus in Silver Spring, Md.

In the Sept. 16 letter, the FDA said it will also publish a revised draft guidance
on “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or
Applicants” by Sept. 30, 2018, and will update the current draft or final guidance
on “Best Practices for Communication Between IND Sponsors and FDA During Drug Development”
by Dec. 31, 2018.

Industry reaction to the letter was generally positive focusing on other aspects besides
interchangeability.

Pharmaceutical Research and Manufacturers of America (PhRMA) President and Chief Executive
Officer Stephen J. Ubl in a Sept. 16 statement noted key provisions of the letter,
including: continued improvement of the efficiency of the science-based FDA review
process for biosimilars; the establishment of dedicated staff capacity for key functions;
ensuring the long-term sustainability of BsUFA activities through modernized time
reporting and capacity planning; and promoting informative engagement between FDA
and biosimilar sponsors during development and review of biosimilar products, for
example, by helping to ensure feedback is provided in a timely manner.

Biotechnology Innovation Organization (BIO) Senior Vice President for Science Policy
Kay Holcombe said in a statement the same day: “Among the many enhancements to the
biosimilars review process envisioned in the goals letter, we are particularly pleased
with the Agency's commitment to establish a program for enhanced communications during
the biosimilars review process. A similar program in PDUFA [the Prescription Drug
User Fee Act] has been tremendously successful in improving communications between
Sponsors and the Agency at key points in the development process, resulting in a more
efficient process for sponsors and the FDA alike.”

To contact the reporter on this story: John T. Aquino in Washington at
jaquino@bna.com

To contact the editor responsible for this story: Randy Kubetin at
rkubetin@bna.com

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